Annex 4 in the draft ICH-GCP E6 (R3) is about data governance. In fact, the content of this guidance is quite similar to the requirements...

A new year always starts with good resolutions for the coming year. What are yours?Why not learn something new? Mine for 2024 is to...

On the 30th of November, we celebrated the 20th anniversary of the KCE (Centre of Expertise in Health Care). It was a very enlightening...

What a difficult question? After all, quality has been mainly the responsibility of quality managers, and now project managers should...

During the last holidays I was thinking about what we do every day in clinical trials and how bureaucratic we are. ICH-GCP R3 clearly...

Even though it is still a draft, it is good to be prepared for this new version of Good Clinical Practice. This is not just an addendum...

Hi everybody, in this blog I will try to share regularly what I learned and still experienced every day when working in Clinical trials...